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FDA News Briefs for Tuesday, January 2, 2018

January 2, 2018

These Food and Drug Administration (FDA) developments came in last week:


FDA Clears dermaPACE Device for Treatment of Diabetic Foot Ulcers

The FDA has granted a de novo classification for the dermaPACE device (Sanuwave Health Inc.), the first shock wave device intended to treat diabetic foot ulcers. The dermaPACE system is an extracorporeal shock wave system that uses pulses of energy to mechanically stimulate the wound; it is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The device is intended for use in adult patients (22 years and older) presenting with diabetic foot ulcers lasting for more than 30 days and should be used along with standard diabetic ulcer care. More Information.


FDA Updates Tasigna Label

The FDA has updated the product label for Tasigna (nilotinib; Novartis) to include information for providers about how to discontinue the drug in certain patients. Tasigna is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). More Information.


FDA Clears GammaPod Stereotactic Radiotherapy System for Use in Treating Breast Cancer

The FDA has granted 510(k) clearance for the GammaPod stereotactic radiotherapy system (Xcision Medical Systems LLC) for use in the noninvasive stereotactic delivery of a radiation dose to a portion of the breast in conjunction with breast conserving treatment. During the procedure, radiation is delivered to specific areas of the breast. The GammaPod has not been shown to be as effective as whole breast radiation therapy (WBRT) and is not intended to replace WBRT. More Information.


FDA Approves HEMOBLAST Bellows for Hemostasis during Surgery

The FDA has approved the HEMOBLAST Bellows (Biom’Up SA), a handheld device used to achieve hemostasis during surgical procedures. Surgeons use the HEMOBLAST Bellows to apply hemostatic powder to the source of the bleeding by squeezing the bellows. The hemostatic powder absorbs excess blood and helps to stop bleeding. More Information.


FDA Expands Approval of Procysbi for Use in Children

The FDA has expanded approval of Procysbi (cysteamine bitartrate; Horizon Pharma USA Inc.) to include use in pediatric patients 1 year of age and older for the treatment of nephropathic cystinosis. Procysbi was previously approved for use in adult and pediatric patients 2 years of age and older. More Information.